Patent foramen ovale closure significantly reduced ischemic stroke recurrence compared to medical treatment (0.53 vs 1.1 per 100 patient-years; OR 0.43; 95% CI 0.21-0.90).
Meta-Analysis (n=3,627)
Does PFO closure reduce ischemic stroke recurrence in patients with cryptogenic stroke or TIA compared to medical treatment?
In patients with cryptogenic stroke or TIA and a PFO, PFO closure significantly reduces the risk of recurrent ischemic stroke compared to medical therapy, though with an increased risk of mostly transient atrial fibrillation.
Odds Ratio: 0.43 (95% CI 0.21–0.9)
Absolute Event Rate: 0.53% vs 1.1%
Absolute Risk Reduction: 2.11%
Number Needed to Treat: 46.5
BACKGROUND AND PURPOSE: Previous systematic reviews and meta-analyses compared the efficacy and safety of patent foramen ovale (PFO) closure versus medical treatment in patients with cryptogenic stroke or transient ischemic attack (TIA). Recently, new evidence from randomized trials became available. METHODS: We searched PubMed until September 24, 2017, for trials comparing PFO closure with medical treatment in patients with cryptogenic stroke/TIA using the items: stroke or cerebrovascular accident or TIA and patent foramen ovale or paradoxical embolism and trial or study. RESULTS: Among 851 identified articles, 5 were eligible. In 3627 patients with 3.7-year mean follow-up, there was significant difference in ischemic stroke recurrence (0.53 versus 1.1 per 100 patient-years, respectively; odds ratio OR, 0.43; 95% confidence intervals (CI), 0.21-0.90; relative risk reduction, 50.5%; absolute risk reduction, 2.11%; and number needed to treat to prevent 1 event, 46.5 for 3.7 years). There was no significant difference in TIAs (0.78 versus 0.98 per 100 patient-years, respectively; OR, 0.80; 95% CI, 0.53-1.19) and all-cause mortality (0.18 versus 0.23 per 100 patient-years, respectively; OR, 0.73; 95% CI, 0.34-1.56). New-onset atrial fibrillation occurred more frequently in the PFO closure arm (1.3 versus 0.25 per 100 patient-years, respectively; OR, 5.15; 95% CI, 2.18-12.15) and resolved in 72% of cases within 45 days, whereas rates of myocardial infarction (0.12 versus 0.09 per 100 patient-years, respectively; OR, 1.22; 95% CI, 0.25-5.91) and any serious adverse events (7.3 versus 7.3 per 100 patient-years, respectively; OR, 1.07; 95% CI, 0.92-1.25) were similar. CONCLUSIONS: In patients with cryptogenic stroke/TIA and PFO who have their PFO closed, ischemic stroke recurrence is less frequent compared with patients receiving medical treatment. Atrial fibrillation is more frequent but mostly transient. There is no difference in TIA, all-cause mortality, or myocardial infarction.
Ntaios et al. (Mon,) conducted a meta-analysis in Cryptogenic stroke or transient ischemic attack (TIA) with patent foramen ovale (PFO) (n=3,627). Patent foramen ovale (PFO) closure vs. Medical treatment was evaluated on Ischemic stroke recurrence (OR 0.43, 95% CI 0.21-0.90). Patent foramen ovale closure significantly reduced ischemic stroke recurrence compared to medical treatment (0.53 vs 1.1 per 100 patient-years; OR 0.43; 95% CI 0.21-0.90).
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